A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Methods (4)
Analyses were performed for weeks 1 to 2, 3 to 6, and 7 to 14. The primary variables were diary card symptom scores, concomitant bronchodilator use, clinician assessment of asthma severity, and clinician and patient opinion of study treatment. Cough scores were analyzed for all patients, and separately, for those patients who recorded cough (score>0.5) during the baseline. Laboratory data were summarized by treatment across the centers. Individual clinically abnormal results were re-evaluated and reviewed. Shift tables for each variable, cross-classifying pretreatment with posttreatment values were prepared. ventolin inhalers
Patients who required prednisone or who were withdrawn because of lack of efficacy were classified as treatment failures, and were included in subsequent analyses using values representative of the worst possible response, ie, symptom score maxima, lowest PEFR, and scores of six for clinician assessment of asthma severity and clinician and patient opinions of treatment. Pulmonary function values were calculated as a percentage (100 percent — [x percent +10 percent]) of the failed patients baseline, where x was the maximum recorded fall from baseline within the clinic study population. A further 10 percent fall was added to give the projected worst possible response had the patient continued in the study. It was not possible to assign a medication score to these patients.